Daytime Nighttime Cold/flu Relief
NDC Package 46084-121-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Daytime Nighttime Cold/flu Relief is •take only as directed – see Overdose warning •take Nighttime OR Daytime.Nighttime tablets •do not exceed 4 doses per 24 hours adults and children 12 years and over  swallow 2 softgels with water every 6 hrs  children 4 to under 12 years  ask a doctor  children under 4 years  do not use DayTime tablets •do not exceed 4 doses per 24 hours adults and children 12 years and over  swallow 2 softgels with water every 4 hrs  children 4 to under 12 years  ask a doctor  children under 4 years  do not use •when using other Daytime or Nighttime products, carefully read each label to insure correct dosing. Marketed by A P J Laboratories Limited, this product is identified by NDC 46084-121 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
46084-121-01
Package Description
1 KIT in 1 PACKAGE * 20 TABLET in 1 BLISTER PACK (46084-122-20) * 20 TABLET in 1 BLISTER PACK (46084-123-20)
Product Code
46084-121
11-Digit Billing Format
46084012101
RxNorm Crosswalk
  • RxCUI: 1094538 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Tablet
  • RxCUI: 1094538 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1094538 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Tablet
  • RxCUI: 1425315 - acetaminophen 325 MG / chlorpheniramine maleate 6.25 MG / dextromethorphan HBr 15 MG Oral Tablet
  • RxCUI: 1425315 - acetaminophen 325 MG / chlorpheniramine maleate 6.25 MG / dextromethorphan hydrobromide 15 MG Oral Tablet

Clinical Specifications

Proprietary Name
Daytime Nighttime Cold/flu Relief A P J
Dosage Form
-
Usage Information
•take only as directed – see Overdose warning •take Nighttime OR Daytime.Nighttime tablets •do not exceed 4 doses per 24 hours adults and children 12 years and over  swallow 2 softgels with water every 6 hrs  children 4 to under 12 years  ask a doctor  children under 4 years  do not use DayTime tablets •do not exceed 4 doses per 24 hours adults and children 12 years and over  swallow 2 softgels with water every 4 hrs  children 4 to under 12 years  ask a doctor  children under 4 years  do not use •when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Regulatory & Marketing

Labeler Name
A P J Laboratories Limited
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
06-01-2013
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 46084-121-01 identifies a specific commercial package of 1 kit in 1 package * 20 tablet in 1 blister pack (46084-122-20) * 20 tablet in 1 blister pack (46084-123-20) of Daytime Nighttime Cold/flu Relief A P J, labeled by A P J Laboratories Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by A P J Laboratories Limited on June 01, 2013. The current certification is valid through December 31, 2017.

How is this A P J Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46084012101. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
46084-121-01
11-Digit CMS (5-4-2)
46084-0121-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.